Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Losartan Potassium + Hydrochlorthiazide 100 mg+12.5 mg Market UK Language English Size 170 x 550 (PIL) Min. Font Size 9 Version No. 1 (Page 1 of 2) Keyline Date 18_01_21 (LPH 100-12.5mg (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance
3 How to take Losartan HCT Not known (frequency cannot be estimated from the available data) tablets - Flu-like symptoms and feeling of general Package leaflet: information for the user discomfort and illness Always take this medicine exactly as your doctor - Generally feeling unwell (malaise) Losartan potassium/Hydrochlorothiazide has told you. Check with your doctor or - Low levels of sodium in the blood pharmacist if you are not sure. Your doctor will (hyponatraemia) 100/12.5mg Film-coated Tablets decide on the appropriate dose of Losartan HCT - Abnormal muscle breakdown tablets depending on your condition and whether you (rhabdomyolysis) with symptoms such as muscle Read all of this leaflet carefully before you start - su er from primary hyperaldosteronism (a are taking other medicines. It is important to continue pain, weakness and swelling which can lead to taking this medicine because it contains syndrome associated with increased secretion of the taking Losartan HCT tablets for as long as your doctor kidney problems (urine can become dark) important information for you. hormone aldosterone by the adrenal gland, caused prescribes it in order to maintain smooth control of - Disturbed taste (dysgeusia) - Dose-related orthostatic e ects such as lowering of - Keep this leaflet. You may need to read it again. by an abnormality within the gland) your blood pressure. - are taking any of the following medicines used to blood pressure appearing when rising from a lying - If you have any further questions, ask your treat high blood pressure: High Blood Pressure or sitting position doctor or pharmacist. - an ACE-inhibitor (for example enalapril, lisinopril, The recommended usual dose of Losartan HCT tablets - Cutaneous lupus erythematosus, which is identi ed - This medicine has been prescribed for you only. ramipril), in particular if you have diabetes-related for most patients with high blood pressure is 1 tablet by a rash that may appear on the face, neck, and Do not pass it on to others. It may harm them, kidney problems. of Losartan HCT 50mg/12.5mg per day to control scalp even if their signs of illness are the same as - aliskiren. blood pressure over the 24-hour period. This can be - Skin and lip cancer (Non-melanoma skin cancer) yours. increased to 2 tablets once daily of - Decrease in vision or pain in your eyes due to high - If you get any side e ects, talk to your doctor or Your doctor may check your kidney function, blood losartan/hydrochlorothiazide 50mg/12.5mg pressure (possible signs of uid accumulation in the pharmacist. This includes any possible side pressure and the amount of electrolytes (e.g. lm-coated tablets or changed to 1 tablet daily of vascular layer of the eye (choroidal e usion) or acute angle-closure glaucoma). e ects not listed in this lea et. See section 4. potassium) in your blood at regular intervals. losartan/hydrochlorothiazide 100mg/25mg - The full name of this medicine is Losartan lm-coated tablets (a stronger strength) per day. The See also information under the heading “Do not take maximum daily dose is 2 tablets per day of Reporting of side e ects potassium/Hydrochlorothiazide 100mg/12.5mg Losartan HCT tablets if you”. losartan/hydrochlorothiazide 50mg/12.5mg If you get any side e ects, talk to your doctor, Film-coated Tablets but within the lea et it will lm-coated tablets or 1 tablet daily of pharmacist or nurse. This includes any possible side be referred to as Losartan HCT tablets. Children and adolescents losartan/hydrochlorothiazide 100mg/25mg e ects not listed in this lea et. You can also report There is no experience with the use of Losartan HCT lm-coated tablets. side e ects directly via the Yellow Card Scheme at: What is in this lea et tablets in children. Therefore Losartan HCT tablets Losartan HCT 100mg/12.5mg is available for patients www.mhra.gov.uk/yellowcard or search for MHRA 1 What Losartan HCT tablets are and what they should not be given to children. who need additional blood pressure control after Yellow Card in the Google Play or Apple App Store. are used for being titrated to 100mg of losartan. By reporting side e ects you can help provide more 2 What you need to know before you take Other medicines and Losartan HCT tablets Tell your doctor or pharmacist if you are taking, have information on the safety of this medicine. Losartan HCT tablets Administration recently taken or might take any other medicines. The tablets should be swallowed whole with a glass of 3 How to take Losartan HCT tablets water. 4 Possible side e ects Tell your doctor if you are taking potassium 5 How to store Losartan HCT tablets 5 How to store Losartan HCT tablets supplements, potassium-containing salt substitutes, If you take more Losartan HCT tablets than you 6 Contents of the pack and other information potassium-sparing medicines, or other medicines that should Keep this medicine out of the sight and reach of may increase serum potassium (e.g. In case of an overdose, contact your doctor children. trimethoprim-containing medicines), as the immediately so that medical attention may be given Do not use this medicine after the expiry date which is 1 What Losartan HCT tablets are and combination with Losartan HCT is not advisable. promptly. An overdose can cause a drop in blood stated on the label and carton after EXP. The expiry pressure, palpitations, slow pulse, changes in blood what they are used for date refers to the last day of that month. Diuretic agents such as the hydrochlorothiazide composition, and dehydration. Store below 30°C and store in the original packaging contained in Losartan HCT tablets may interact with in order to protect from moisture. Losartan HCT tablets are a combination of an other medicines. If you forget to take Losartan HCT tablets angiotensin II receptor antagonist (losartan) and a Try to take Losartan HCT tablets daily as prescribed. Do Do not throw away any medicines via wastewater or diuretic (hydrochlorothiazide). Angiotensin II is a Preparations containing lithium should not be taken not take a double dose to make up for a forgotten dose. household waste. Ask your pharmacist how to throw substance produced in the body which binds to with Losartan HCT tablets without close supervision Just resume your usual schedule. away medicines you no longer use. These measures receptors in blood vessels, causing them to tighten. by your doctor. will help protect the environment. This results in an increase in blood pressure. Losartan If you have any further questions on the use of this prevents the binding of angiotensin II to these Special precautionary measures (e.g. blood tests) may product, ask your doctor or pharmacist. receptors, causing the blood vessels to relax which in be appropriate if you take other diuretics (“water turn lowers the blood pressure. Hydrochlorothiazide tablets”), some laxatives, glycyrrhizin (found in 6 Contents of the pack and other works by making the kidneys pass more water and liquorice), medicines for the treatment of gout, 4 Possible side e ects information salt. This also helps to reduce blood pressure. medicines to control heart rhythm or for diabetes What Losartan HCT tablets contain (oral agents or insulins). Like all medicines, this medicine can cause side Losartan HCT tablets are indicated for the treatment - The active substances are losartan potassium and e ects, although not everybody gets them. of essential hypertension (high blood pressure). It is also important for your doctor to know if you are hydrochlorothiazide. Each Losartan HCT 100mg/12.5mg tablet contains taking: If you experience the following, stop taking Losartan 100mg losartan potassium and 12.5mg 2 What you need to know before you - other medicines to reduce your blood pressure HCT tablets and tell your doctor immediately or go to hydrochlorothiazide. take Losartan HCT tablets - steroids the casualty department of your nearest hospital: - medicines to treat cancer - The other ingredients are: - Tablet core: mannitol (E421), microcrystalline Do not take Losartan HCT tablets if you - painkillers A severe allergic reaction (rash, itching, swelling of the cellulose, croscarmellose sodium, povidone (K-30), - are allergic to losartan, hydrochlorothiazide or to - drugs for treatment of infections, including fungal face, lips, mouth or throat that may cause di culty in magnesium stearate. any of the other ingredients of this medicine (listed infections swallowing or breathing). Film-coating:Hypromellose (6cP), macrogol 8000, in section 6) - arthritis medicines yellow iron oxide (E172), talc, titanium dioxide - are allergic (hypersensitive) to other - resins used for high cholesterol, such as This is a serious but rare side e ect, which a ects (E171) sulfonamide-derived substances (e. g. other colestyramine more than 1 out of 10,000 patients but fewer than 1 thiazides, some antibacterial drugs such as - medicines which relax your muscles out of 1,000 patients. You may need urgent medical What Losartan HCT tablets looks like and contents co-trimoxazole, ask your doctor if you are not sure) - sleeping tablets attention or hospitalisation. of the pack - have severely impaired liver function - opioid medicines such as morphine Losartan HCT 100mg/12.5mg tablets are yellow - are more than 3 months pregnant (it is also better - “pressor amines” such as adrenaline or The following side e ects have been reported: coloured, 10 mm, round shaped, biconvex lm coated to avoid Losartan HCT tablets in early pregnancy - other drugs from the same group tablets debossed with “KK2” on one side and plain on see pregnancy section) - oral agents for diabetes or insulins Common (may a ect up to 1 in 10 people) other side - have severely impaired kidney function or your - anticholinergic agents (e.g. atropine, - Cough, upper airway infection, congestion in kidneys are not producing any urine biperiden) the nose, sinusitis, sinus disorder Pack sizes - have low potassium, low sodium or high calcium - antipsychotics - Diarrhoea, abdominal pain, nausea, 28 lm-coated tablets levels which cannot be corrected by treatment - antidepressants indigestion - are su ering from gout - carbamazepine. - Muscle pain or cramps, leg pain, back pain Marketing Authorisation Holder - have diabetes or impaired kidney function and you - Insomnia, headache, dizziness Accord, Barnstaple, EX32 8NS, UK are treated with a blood pressure lowering medicine Please also inform your doctor you are taking - Weakness, tiredness, chest pain
containing aliskiren. Losartan HCT tablets if you will be undergoing a - Increased potassium levels (which can cause an Manufacturers radiographic procedure and will be given iodine abnormal heart rhythm), decreased haemoglobin Actavis Ltd. Warnings and precautions contrast media. levels BLB 016, Bulebel Industrial Estate, Talk to your doctor or pharmacist before taking - Changes in kidney function including kidney failure Zejtun, ZTN 3000, Losartan HCT. Losartan HCT tablets with food and drink and - Low blood sugar (hypoglycaemia). alcohol Malta You must tell your doctor if you think you are (or You are advised not to drink alcohol whilst taking Uncommon (may a ect up to 1 in 100 people) Or might become) pregnant. Losartan HCT tablets are these tablets: alcohol and Losartan HCT tablets may - Anaemia, red or brownish spots on the skin Accord Healthcare Polska Sp.z.o.o. not recommended in early pregnancy, and must not increase each other’s e ects. (sometimes especially on the feet, legs, arms and Ul. Lutomierska 50, 95-200, Pabianice, Poland. be taken if you are more than 3 months pregnant, as it Dietary salt in excessive quantities may counteract the buttocks, with joint pain, swelling of the hands and may cause serious harm to your baby if used at that e ect of Losartan HCT tablets. feet and stomach pain), bruising, reduction in white Or stage (see pregnancy section). Losartan HCT tablets may be taken with or without blood cells, clotting problems, reduced number of Accord Healthcare B.V. food. platelets Winthontlaan 200, 3526KV Utrecht, The Netherlands It is important to tell your doctor before taking - Loss of appetite, increased uric acid levels or frank Losartan HCT tablets if you: Pregnancy and breast-feeding gout, increased blood sugar levels, abnormal blood This lea et was last revised in March 2021 - have previously su ered from swelling of the face, If you are pregnant or breast-feeding, think you may electrolyte levels lips, throat or tongue be pregnant or are planning to have a baby, ask your - Anxiety, nervousness, panic disorder (recurring - take diuretics (water pills) doctor or pharmacist for advice before taking this panic attacks), confusion, depression, abnormal - are on a salt-restricted diet medicine. dreams, sleep disorders, sleepiness, memory If you would like a lea et with - have or have had severe vomiting and/or diarrhoea impairment larger text, please contact - have heart failure Pregnancy - Pins and needles or similar sensations, pain in the - have narrow arteries to your kidneys (renal artery You must tell your doctor if you think you are (or extremities, trembling, migraine, fainting 01271 385257. stenosis) or only have one functioning kidney, or might become) pregnant. Your doctor will normally - Blurred vision, burning or stinging in the eyes, you have recently had a kidney transplant advise you to stop taking Losartan HCT tablets before conjunctivitis, worsening eyesight, seeing things in - have narrowing of the arteries (atherosclerosis), you become pregnant or as soon as you know you are yellow angina pectoris (chest pain due to poor heart pregnant and will advise you to take another - Ringing, buzzing, roaring or clicking in the ears, function) medicine instead of Losartan HCT tablets. Losartan vertigo - have ‘aortic or mitral valve stenosis’ (narrowing of HCT tablets are not recommended during pregnancy, - Low blood pressure, which may be associated with the valves of the heart) or ‘hypertrophic and must not be taken when more than 3 months changes in posture (feeling light-headed or weak cardiomyopathy’ (a disease causing thickening of pregnant, as it may cause serious harm to your baby if when you stand up), angina (chest pain), abnormal heart muscle) used after the third month of pregnancy. heartbeat, cerebrovascular accident (TIA, - have a history of mild to moderate liver impairment “mini-stroke”), heart attack, palpitations - are diabetic Breastfeeding - In ammation of blood vessels, which is often - have had gout Tell your doctor if you are breast-feeding or about to associated with a skin rash or bruising - have or have had an allergic condition, asthma or start breast-feeding. Losartan HCT tablets are not - Sore throat, breathlessness, bronchitis, pneumonia, a condition that causes joint pain, skin rashes and recommended for mothers who are breast-feeding, water on the lungs (which causes di culty fever (systemic lupus erythematosus) and your doctor may choose another treatment for breathing), nosebleed, runny nose, congestion - have had skin cancer or if you develop an you if you wish to breast-feed. - Constipation, obstipation, wind, stomach upsets, unexpected skin lesion during the treatment. stomach spasms, vomiting, dry mouth, Treatment with hydrochlorothiazide, particularly Use in elderly patients in ammation of a salivary gland, toothache long term use with high doses, may increase the risk Losartan HCT tablets work equally well in and are - Jaundice (yellowing of the eyes and skin), of some types of skin and lip cancer (non-melanoma equally well tolerated by most older and younger in ammation of the pancreas skin cancer). Protect your skin from sun exposure adult patients. Most older patients require the same - Hives, itching, in ammation of the skin, rash, and UV rays while taking Losartan HCT tablets dose as younger patients. redness of the skin, sensitivity to light, dry skin, - experience a decrease in vision or eye pain. These ushing, sweating, hair loss could be symptoms of uid accumulation in the Driving and using machines - Pain in the arms, shoulders, hips, knees or other vascular layer of the eye (choroidal e usion) or an When you begin treatment with this medication, you joints, joint swelling, sti ness, muscle weakness increase of pressure in your eye and can happen should not perform tasks which may require special - Frequent urination including at night, abnormal within hours to a week of taking Losartan HCT tablets. attention (for example, driving a car or operating kidney function including in ammation of the This can lead to permanent vision loss if not treated. If dangerous machinery) until you know how you kidneys, urinary infection, sugar in the urine you earlier have had a penicillin or sulfonamide tolerate your medicine. - Decreased sexual appetite, impotence allergy, you can be at higher risk of developing this - Swelling of the face, localised swelling (oedema), - have high calcium or low potassium levels or you Losartan HCT tablets contain sodium. fever. are on a low potassium diet This medicine contains less than 1 mmol sodium - need to have an anaesthetic (even at the dentist) or (23 mg) per tablet, that is to say essentially Rare (may a ect up to 1 in 1,000 people) before surgery, or if you are going to have tests to ‘sodium-free’. - Hepatitis (in ammation of the liver), abnormal liver check your parathyroid function, you must tell the function tests. doctor or medical sta that you are taking Losartan HCT tablets Continued top of next column Continued over page
Front Side
(6007151): 25/02/21, 25/03/21, 30/03/21 Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Losartan Potassium + Hydrochlorthiazide 100 mg+12.5 mg Market UK Language English Size 170 x 550 (PIL) Min. Font Size 9 Version No. 1 (Page 2 of 2) Keyline Date 18_01_21 (LPH 100-12.5mg (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance
3 How to take Losartan HCT Not known (frequency cannot be estimated from the available data) tablets - Flu-like symptoms and feeling of general discomfort and illness Always take this medicine exactly as your doctor - Generally feeling unwell (malaise) has told you. Check with your doctor or - Low levels of sodium in the blood pharmacist if you are not sure. Your doctor will (hyponatraemia) decide on the appropriate dose of Losartan HCT - Abnormal muscle breakdown tablets depending on your condition and whether you (rhabdomyolysis) with symptoms such as muscle Read all of this leaflet carefully before you start - su er from primary hyperaldosteronism (a are taking other medicines. It is important to continue pain, weakness and swelling which can lead to taking this medicine because it contains syndrome associated with increased secretion of the taking Losartan HCT tablets for as long as your doctor kidney problems (urine can become dark) important information for you. hormone aldosterone by the adrenal gland, caused prescribes it in order to maintain smooth control of - Disturbed taste (dysgeusia) - Dose-related orthostatic e ects such as lowering of - Keep this leaflet. You may need to read it again. by an abnormality within the gland) your blood pressure. - are taking any of the following medicines used to blood pressure appearing when rising from a lying - If you have any further questions, ask your treat high blood pressure: High Blood Pressure or sitting position doctor or pharmacist. - an ACE-inhibitor (for example enalapril, lisinopril, The recommended usual dose of Losartan HCT tablets - Cutaneous lupus erythematosus, which is identi ed - This medicine has been prescribed for you only. ramipril), in particular if you have diabetes-related for most patients with high blood pressure is 1 tablet by a rash that may appear on the face, neck, and Do not pass it on to others. It may harm them, kidney problems. of Losartan HCT 50mg/12.5mg per day to control scalp even if their signs of illness are the same as - aliskiren. blood pressure over the 24-hour period. This can be - Skin and lip cancer (Non-melanoma skin cancer) yours. increased to 2 tablets once daily of - Decrease in vision or pain in your eyes due to high - If you get any side e ects, talk to your doctor or Your doctor may check your kidney function, blood losartan/hydrochlorothiazide 50mg/12.5mg pressure (possible signs of uid accumulation in the pharmacist. This includes any possible side pressure and the amount of electrolytes (e.g. lm-coated tablets or changed to 1 tablet daily of vascular layer of the eye (choroidal e usion) or acute angle-closure glaucoma). e ects not listed in this lea et. See section 4. potassium) in your blood at regular intervals. losartan/hydrochlorothiazide 100mg/25mg - The full name of this medicine is Losartan lm-coated tablets (a stronger strength) per day. The See also information under the heading “Do not take maximum daily dose is 2 tablets per day of Reporting of side e ects potassium/Hydrochlorothiazide 100mg/12.5mg Losartan HCT tablets if you”. losartan/hydrochlorothiazide 50mg/12.5mg If you get any side e ects, talk to your doctor, Film-coated Tablets but within the lea et it will lm-coated tablets or 1 tablet daily of pharmacist or nurse. This includes any possible side be referred to as Losartan HCT tablets. Children and adolescents losartan/hydrochlorothiazide 100mg/25mg e ects not listed in this lea et. You can also report There is no experience with the use of Losartan HCT lm-coated tablets. side e ects directly via the Yellow Card Scheme at: What is in this lea et tablets in children. Therefore Losartan HCT tablets Losartan HCT 100mg/12.5mg is available for patients www.mhra.gov.uk/yellowcard or search for MHRA 1 What Losartan HCT tablets are and what they should not be given to children. who need additional blood pressure control after Yellow Card in the Google Play or Apple App Store. are used for being titrated to 100mg of losartan. By reporting side e ects you can help provide more 2 What you need to know before you take Other medicines and Losartan HCT tablets Tell your doctor or pharmacist if you are taking, have information on the safety of this medicine. Losartan HCT tablets Administration recently taken or might take any other medicines. The tablets should be swallowed whole with a glass of 3 How to take Losartan HCT tablets water. 4 Possible side e ects Tell your doctor if you are taking potassium 5 How to store Losartan HCT tablets 5 How to store Losartan HCT tablets supplements, potassium-containing salt substitutes, If you take more Losartan HCT tablets than you 6 Contents of the pack and other information potassium-sparing medicines, or other medicines that should Keep this medicine out of the sight and reach of may increase serum potassium (e.g. In case of an overdose, contact your doctor children. trimethoprim-containing medicines), as the immediately so that medical attention may be given Do not use this medicine after the expiry date which is 1 What Losartan HCT tablets are and combination with Losartan HCT is not advisable. promptly. An overdose can cause a drop in blood stated on the label and carton after EXP. The expiry pressure, palpitations, slow pulse, changes in blood what they are used for date refers to the last day of that month. Diuretic agents such as the hydrochlorothiazide composition, and dehydration. Store below 30°C and store in the original packaging contained in Losartan HCT tablets may interact with in order to protect from moisture. Losartan HCT tablets are a combination of an other medicines. If you forget to take Losartan HCT tablets angiotensin II receptor antagonist (losartan) and a Try to take Losartan HCT tablets daily as prescribed. Do Do not throw away any medicines via wastewater or diuretic (hydrochlorothiazide). Angiotensin II is a Preparations containing lithium should not be taken not take a double dose to make up for a forgotten dose. household waste. Ask your pharmacist how to throw substance produced in the body which binds to with Losartan HCT tablets without close supervision Just resume your usual schedule. away medicines you no longer use. These measures receptors in blood vessels, causing them to tighten. by your doctor. will help protect the environment. This results in an increase in blood pressure. Losartan If you have any further questions on the use of this prevents the binding of angiotensin II to these Special precautionary measures (e.g. blood tests) may product, ask your doctor or pharmacist. receptors, causing the blood vessels to relax which in be appropriate if you take other diuretics (“water turn lowers the blood pressure. Hydrochlorothiazide tablets”), some laxatives, glycyrrhizin (found in 6 Contents of the pack and other works by making the kidneys pass more water and liquorice), medicines for the treatment of gout, 4 Possible side e ects information salt. This also helps to reduce blood pressure. medicines to control heart rhythm or for diabetes What Losartan HCT tablets contain (oral agents or insulins). Like all medicines, this medicine can cause side Losartan HCT tablets are indicated for the treatment - The active substances are losartan potassium and e ects, although not everybody gets them. of essential hypertension (high blood pressure). It is also important for your doctor to know if you are hydrochlorothiazide. Each Losartan HCT 100mg/12.5mg tablet contains taking: If you experience the following, stop taking Losartan 100mg losartan potassium and 12.5mg 2 What you need to know before you - other medicines to reduce your blood pressure HCT tablets and tell your doctor immediately or go to hydrochlorothiazide. take Losartan HCT tablets - steroids the casualty department of your nearest hospital: - medicines to treat cancer - The other ingredients are: - Tablet core: mannitol (E421), microcrystalline Do not take Losartan HCT tablets if you - painkillers A severe allergic reaction (rash, itching, swelling of the cellulose, croscarmellose sodium, povidone (K-30), - are allergic to losartan, hydrochlorothiazide or to - drugs for treatment of infections, including fungal face, lips, mouth or throat that may cause di culty in magnesium stearate. any of the other ingredients of this medicine (listed infections swallowing or breathing). Film-coating:Hypromellose (6cP), macrogol 8000, in section 6) - arthritis medicines yellow iron oxide (E172), talc, titanium dioxide - are allergic (hypersensitive) to other - resins used for high cholesterol, such as This is a serious but rare side e ect, which a ects (E171) sulfonamide-derived substances (e. g. other colestyramine more than 1 out of 10,000 patients but fewer than 1 thiazides, some antibacterial drugs such as - medicines which relax your muscles out of 1,000 patients. You may need urgent medical What Losartan HCT tablets looks like and contents co-trimoxazole, ask your doctor if you are not sure) - sleeping tablets attention or hospitalisation. of the pack - have severely impaired liver function - opioid medicines such as morphine Losartan HCT 100mg/12.5mg tablets are yellow - are more than 3 months pregnant (it is also better - “pressor amines” such as adrenaline or The following side e ects have been reported: coloured, 10 mm, round shaped, biconvex lm coated to avoid Losartan HCT tablets in early pregnancy - other drugs from the same group tablets debossed with “KK2” on one side and plain on see pregnancy section) - oral agents for diabetes or insulins Common (may a ect up to 1 in 10 people) other side - have severely impaired kidney function or your - anticholinergic agents (e.g. atropine, - Cough, upper airway infection, congestion in kidneys are not producing any urine biperiden) the nose, sinusitis, sinus disorder Pack sizes - have low potassium, low sodium or high calcium - antipsychotics - Diarrhoea, abdominal pain, nausea, 28 lm-coated tablets levels which cannot be corrected by treatment - antidepressants indigestion - are su ering from gout - carbamazepine. - Muscle pain or cramps, leg pain, back pain Marketing Authorisation Holder - have diabetes or impaired kidney function and you - Insomnia, headache, dizziness Accord, Barnstaple, EX32 8NS, UK are treated with a blood pressure lowering medicine Please also inform your doctor you are taking - Weakness, tiredness, chest pain containing aliskiren. Losartan HCT tablets if you will be undergoing a - Increased potassium levels (which can cause an Manufacturers radiographic procedure and will be given iodine abnormal heart rhythm), decreased haemoglobin Actavis Ltd. Warnings and precautions contrast media. levels BLB 016, Bulebel Industrial Estate, Talk to your doctor or pharmacist before taking - Changes in kidney function including kidney failure Zejtun, ZTN 3000, Losartan HCT. Losartan HCT tablets with food and drink and - Low blood sugar (hypoglycaemia). alcohol Malta You must tell your doctor if you think you are (or You are advised not to drink alcohol whilst taking Uncommon (may a ect up to 1 in 100 people) Or might become) pregnant. Losartan HCT tablets are these tablets: alcohol and Losartan HCT tablets may - Anaemia, red or brownish spots on the skin Accord Healthcare Polska Sp.z.o.o. not recommended in early pregnancy, and must not increase each other’s e ects. (sometimes especially on the feet, legs, arms and Ul. Lutomierska 50, 95-200, Pabianice, Poland. be taken if you are more than 3 months pregnant, as it Dietary salt in excessive quantities may counteract the buttocks, with joint pain, swelling of the hands and may cause serious harm to your baby if used at that e ect of Losartan HCT tablets. feet and stomach pain), bruising, reduction in white Or stage (see pregnancy section). Losartan HCT tablets may be taken with or without blood cells, clotting problems, reduced number of Accord Healthcare B.V. food. platelets Winthontlaan 200, 3526KV Utrecht, The Netherlands It is important to tell your doctor before taking - Loss of appetite, increased uric acid levels or frank Losartan HCT tablets if you: Pregnancy and breast-feeding gout, increased blood sugar levels, abnormal blood This lea et was last revised in March 2021 - have previously su ered from swelling of the face, If you are pregnant or breast-feeding, think you may electrolyte levels lips, throat or tongue be pregnant or are planning to have a baby, ask your - Anxiety, nervousness, panic disorder (recurring - take diuretics (water pills) doctor or pharmacist for advice before taking this panic attacks), confusion, depression, abnormal - are on a salt-restricted diet medicine. dreams, sleep disorders, sleepiness, memory If you would like a lea et with - have or have had severe vomiting and/or diarrhoea impairment larger text, please contact - have heart failure Pregnancy - Pins and needles or similar sensations, pain in the - have narrow arteries to your kidneys (renal artery You must tell your doctor if you think you are (or extremities, trembling, migraine, fainting 01271 385257. stenosis) or only have one functioning kidney, or might become) pregnant. Your doctor will normally - Blurred vision, burning or stinging in the eyes, you have recently had a kidney transplant advise you to stop taking Losartan HCT tablets before conjunctivitis, worsening eyesight, seeing things in - have narrowing of the arteries (atherosclerosis), you become pregnant or as soon as you know you are yellow angina pectoris (chest pain due to poor heart pregnant and will advise you to take another - Ringing, buzzing, roaring or clicking in the ears, function) medicine instead of Losartan HCT tablets. Losartan vertigo - have ‘aortic or mitral valve stenosis’ (narrowing of HCT tablets are not recommended during pregnancy, - Low blood pressure, which may be associated with the valves of the heart) or ‘hypertrophic and must not be taken when more than 3 months changes in posture (feeling light-headed or weak cardiomyopathy’ (a disease causing thickening of pregnant, as it may cause serious harm to your baby if when you stand up), angina (chest pain), abnormal heart muscle) used after the third month of pregnancy. heartbeat, cerebrovascular accident (TIA, - have a history of mild to moderate liver impairment “mini-stroke”), heart attack, palpitations - are diabetic Breastfeeding - In ammation of blood vessels, which is often - have had gout Tell your doctor if you are breast-feeding or about to associated with a skin rash or bruising - have or have had an allergic condition, asthma or start breast-feeding. Losartan HCT tablets are not - Sore throat, breathlessness, bronchitis, pneumonia, a condition that causes joint pain, skin rashes and recommended for mothers who are breast-feeding, water on the lungs (which causes di culty fever (systemic lupus erythematosus) and your doctor may choose another treatment for breathing), nosebleed, runny nose, congestion - have had skin cancer or if you develop an you if you wish to breast-feed. - Constipation, obstipation, wind, stomach upsets, unexpected skin lesion during the treatment. stomach spasms, vomiting, dry mouth, Treatment with hydrochlorothiazide, particularly Use in elderly patients in ammation of a salivary gland, toothache long term use with high doses, may increase the risk Losartan HCT tablets work equally well in and are - Jaundice (yellowing of the eyes and skin), of some types of skin and lip cancer (non-melanoma equally well tolerated by most older and younger in ammation of the pancreas skin cancer). Protect your skin from sun exposure adult patients. Most older patients require the same - Hives, itching, in ammation of the skin, rash, and UV rays while taking Losartan HCT tablets dose as younger patients. redness of the skin, sensitivity to light, dry skin, - experience a decrease in vision or eye pain. These ushing, sweating, hair loss could be symptoms of uid accumulation in the Driving and using machines - Pain in the arms, shoulders, hips, knees or other vascular layer of the eye (choroidal e usion) or an When you begin treatment with this medication, you joints, joint swelling, sti ness, muscle weakness increase of pressure in your eye and can happen should not perform tasks which may require special - Frequent urination including at night, abnormal within hours to a week of taking Losartan HCT tablets. attention (for example, driving a car or operating kidney function including in ammation of the This can lead to permanent vision loss if not treated. If dangerous machinery) until you know how you kidneys, urinary infection, sugar in the urine you earlier have had a penicillin or sulfonamide tolerate your medicine. - Decreased sexual appetite, impotence allergy, you can be at higher risk of developing this - Swelling of the face, localised swelling (oedema), - have high calcium or low potassium levels or you Losartan HCT tablets contain sodium. fever. are on a low potassium diet This medicine contains less than 1 mmol sodium - need to have an anaesthetic (even at the dentist) or (23 mg) per tablet, that is to say essentially Rare (may a ect up to 1 in 1,000 people) before surgery, or if you are going to have tests to ‘sodium-free’. - Hepatitis (in ammation of the liver), abnormal liver check your parathyroid function, you must tell the function tests. doctor or medical sta that you are taking Losartan HCT tablets INP113 Continued top of next column 10 5014 0 6007151
Back Side
(6007151): 25/02/21, 25/03/21, 30/03/21